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Process to understand the toxic effects of Irinotecan drug on Neuroendocrine cancer patients with UGT1A1 gene modifications: A single center study

Evaluation of UGT1A1 gene polymorphism and Irinotecan toxicity in patients of neuroendocrine carcinoma: A single center comparative observational study - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/088969
Enrollment
50
Registered
2025-06-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C7A8- Other malignant neuroendocrine tumors

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Mahamana Pandit Madan Mohan Malviya Cancer Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA: For group of patients who developed toxicity post-irinotecan: Histopathological confirmed incident cases of Neuroendocrine Carcinomas undergoing chemotherapy who reported toxicity after chemotherapy during the study period. For group of patients who did not develop toxicity post-irinotecan: Histopathological confirmed incident cases of Neuroendocrine carcinomas undergoing chemotherapy without any reported toxicity after chemotherapy during the study period.

Exclusion criteria

Exclusion criteria: Patients less than 18 years of age Pregnant and Lactating patients

Design outcomes

Primary

MeasureTime frame
Primary outcome - Proportion of NEC patients on Irinotecan that had polymorphism of UGT11A1 among the cases and controlsTimepoint: All enrolled participants will be assessed for the outcomes after the completion of chemotherapy cycles that is after3 months

Secondary

MeasureTime frame
Correlation of the UGT1A1 polymorphism, toxicity with other variables collected in the study.Timepoint: Will be assessed after 3 months of enrollment of the patient that is after completion of chemotherapy

Countries

India

Contacts

Public ContactPratibha Gavel

Homi Bhabha Cancer Hospital , Varanasi

kamal232394@gmail.com9670061741

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026